Late on Friday, 8 February, Bob Miller announced the end of his hunger strike to get Ampligen approved for people with ME/CFS.

Our community had never seen anything like this and I hope we never have to again. It hasn’t been easy watching Bob get weaker and weaker on his video diary and I’m sure there’s a collective sigh of relief going around the world as people hear the news.

Bob made the announcement on his Facebook page and asked us to now stop sending mass emails to the federal agencies and turn our efforts towards contributing to the FDA Stakeholders Meeting:

Dear Friends,​

We, as a community, accomplished some very important things during the last few weeks, and so I am ending my hunger strike tonight. I am committed to working with our federal health agencies to bring a stronger focus and program to bear on ME/CFS for all of us. The most important thing patients did in recent days was come together. When we commit to each other in the way we all did these last two weeks, we can make great strides toward treatments and understanding of ME/CFS.​

I believe we have made the following accomplishments:​

1. Dr. Wanda Jones, who I trust and respect, in the Assistant Secretary of Health’s office has engaged with the Secretary of Health over the past days on the need for a serious commitment to address our unmet needs.​

2. Dr. Jones committed to me that the Secretary’s office will be engaged in the FDA Stakeholder Meeting this Spring to make it a successful meeting in promoting the need and path forward toward evidence-based treatments.​

3. For the first time, Secretary Kathleen Sebelius met with a few ME/CFS patients from her universe to understand directly the complexity, unmet need, and frustration of patients.​

4. Senate Majority Leader Harry Reid, my senator, advocated for ME/CFS patients at the highest level this week, and I am deeply grateful. He and Senator Kay Hagan were instrumental in raising the seriousness of patients’ unmet need and elevating the importance of a strong FDA Stakeholders Meeting for our future. I know many other Senators and Congresspeople engaged, and that is important to our future efforts.​

There are two things we need to do now:​

1. Stop doing mass emails to the federal agencies, and​

2. Now turn our efforts toward making a thoughtful contribution to the FDA Stakeholders Meeting, so that we can advance treatments with a smart, strong push from the patient community.​

I want to stress that it is important that patients work with those in our federal health agencies who will work with our community seriously. I always will. Thank everyone you know for helping to make this action successful, and we especially thank Dr. Wanda Jones for her leadership.​

Thank you all for being some of my strength and supporting my family in these challenging days.​

Kindly,​

Robert Miller​

Video to come!​

We can follow Bob’s updates on his Facebook page. I’m sure we all wish him a speedy recovery from his ordeal. We owe him a great deal.

Before the FDA Stakeholders Meeting are 2 other very important events and these are from the Hemispherx press release on the Ampligen non-approval: “end-of-review conference with the FDA as a precursor to submitting a formal appeal … regarding the Agency's decision.”

I believe the FDA Stakeholders Meeting is just to calm us down and we will still not have an approved drug for many years. From the many CFS Advisory Committee meetings, the FDA stakeholder teleconference on Sep 13, the many emails and testimonies the FDA should have had a good understanding that we need approval of Ampligen now. But they have decided not to adopt their approval requirements to the unmet medical needs of this serious and life-threatening disease as the FDA made me believe in the FDA stakeholder teleconference on Sep 13.

So I think we still need to act that Hemispherx is successful with their formal appeal, that Ampligen is approved now and the trials with the NIH will follow post-approval. Otherwise there will be no approved drug for many years.

You make a good point. The FDA has so far paid lip service to CFS being a serious and life threatening disease, now they need to produce an action that, at the very least, moves ampligen and other drug development to a near term possibility. However, IMO, I don't think they are going to approve ampligen on an appeal, - I think they will want one more trial. There must be a better fit for Hemispherx, other than a large, expensive, long drawn out phase III. Here are some questions I'd like to know the answer to before the spring stakeholders meeting.

The FDA met last week to discuss a New Pathway To Approval for Serious and Life Threatening diseases. The idea is to focus smaller and quicker trials for quikcer approval on the most serious afflicted and then expand to the labeling later to include the not as serious afficted.

If passed, how can the New Pathway to Approval, if passed, help Hemispherx?

In the September 13 Stakeholders meeting, the FDA touted the new FDASIA statute as a possible fit for Ampligen and Hemispherx. Is FDASIA still a possibility for Hemispherx and if not, why not?

In the September 13 Stakeholders meeting, the FDA stated that they had some other drugs under consideration but when pressed, these turned out only to be Supplements. Why is the FDA considering supplements for a serious and life threatening disease, when real and effective therapeutics are needed? And why, in the 20 years that Hemispherx has been developing Ampligen, there are no other drug makers developing real and effective therapeutics for this disease?

There should probably be some separate thread to start building a case for the Spring Stakeholders meeting. And I mean build a strong case.

Ampligen
there are two viable options still open to get Ampligen legalised and designated for CFIDS / ME.

1. Hemispherx is unlikely to win its appeal to the FDA, though it is still worth a try. There is a high probability of them losing the appeal. To counteract this injustice, many CFIDS / ME organisations throughout America and Europe and Australasia could make an agreement to jointly fund a legal case to the US Federal court or the US Supreme court demanding that Ampligen be legalised and designated for subgroups of CFIDS patients, as efficacy has been proven in a certain percentage of patients (the subgroups), on the legal grounds of medical necessity including life and death issues, and on the grounds of human rights. Some law firms may take this case on at a reduced or lowered fee and if someone has family or friends who are partners in law firms then one could get the case for free. There are some conscientious lawyers still around. If we could set a legal precedent for this in the US Supreme court we could over-turn and over-ride the corruption in the FDA now and in the future, which would work for the benefit of CFIDS and other neglected disabilities. We must remember that the government and its agencies are there to serve the people, including respecting their Constitutional rights and human rights.

2. Hemispherx may not be able to afford more detailed clinical trials with large populations. So in addition to the above legal case, get the NIH involved in a full scale Ampligen trial. Get them to run very detailed tests of Ampligen on those CFIDS subgroups which are benefitting or have benefitted from Ampligen. This would include full recoveries and those people who improved 70 - 100% of normal function. This trial would include deciphering the biological pathways and mechanisms involved and gene changes and expressions involved in the Ampligen responders. Some of these biomarkers are catalogued on www.cfs-ireland.com
And differentiating these CFIDS subgroups from other subgroups which don't respond to Ampligen. This precision analysis by the NIH would then enable the Ampligen responders to be identified from CFIDS populations and subgroups before Ampligen is even administered. Thus treatment with Ampligen would be 100% effective in the identified subgroups, and both efficacy and safety proved beyond reasonable doubt. This NIH trial could be concluded within 6 months. The NIH findings would force the FDA to legalise and designate Ampligen for CFIDS. A similar NIH trial could be undertaken for Rituximab and similar type drugs. And again if successful the FDA could be forced to comply and legalise and designate these drugs also.

A late-stage change in clinical direction and the use of a trial placebo that turned out also to be a treatment in chronic fatigue syndrome (CFS) may have hobbled Hemispherx Bioscience Inc.'s regulatory efforts with Ampligen (rintatolimod), the Toll-like receptor 3 modulator that was hit with a complete response letter (CRL) earlier this month.

But Ampligen may still have a chance, said Kimberly McCleary, president and CEO of the Chronic Fatigue and Immune Dysfunction Syndrome (CFIDS) Association of America.

The scenario "cries out for [Hemispherx] to take on a capable partner, whether that's the National Institutes of Health [NIH] or a company with more experience and some ability to provide the kind of financing that would be required," McCleary said.

"It's a shame that Hemispherx didn't undertake the Phase III [trial] they had planned, and is evident in their [quarterly statements] after the 2009 CRL," she said. "They outlined the cost per patient, and how they would trim down the costs from the last study they did, and then the strategy shifted to submitting a new analysis of the data" from the earlier, AMP516 trial.

Saline was used as the placebo control in the 516 study. "They made that decision back in the early 1990s, before anybody had connected the orthostatic and blood-volume problems in CFS," and before physicians had begun to use saline as a therapy for those problems, McCleary said. "This may have made it more difficult to show efficacy. What is the appropriate placebo, if saline has some active properties?"

Others trying to come up with therapies for CSF will face the same question. But there aren't any others, at least not in advanced stages, doing so, which means patients have all their chips on Ampligen, which already has helped many in trials. These include Robert Miller, 54, whose hunger strike to draw attention to the issue has entered its second week. (See BioWorld Today, Feb. 6, 2013.)

This is another article by Randy Osborne - the third in a series. We're really lucky to have him writing about this - let's follow that link so that he gets the well-deserved traffic to show his editor so that he can keep covering the story.

As Johnny says, that's only part of the article - there's good stuff in the other two thirds!